EARLY: Educational Intervention to Improve Patient Awareness on Early LDL-C Lowering in Secondary… (NCT07252388) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
EARLY: Educational Intervention to Improve Patient Awareness on Early LDL-C Lowering in Secondary Prevention
Italy240 participantsStarted 2025-12-11
Plain-language summary
Cluster Randomized Trial to test the effectiveness of a patient level delivered educational intervention to improve the awareness on the relevance of obtaining LDL cholesterol recommended goals in patients admitted for an acute coronary syndrome, as compared to usual care. Overall, 24 sites (Coronary Care Units) will be included in the study, 12 randomized to the intervention and 12 to usual care. Overall, 240 patients will be enrolled during an acute coronary syndrome hospitalization.
Who can participate
Age range
18 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥18 and \<80 years old.
. Males and females at birth.
. Baseline LDL-Cholesterol:
. Discharged at home
. Ability to understand the requirements of the study and to provide informed consent
Exclusion criteria
. Patients who have previously received or currently treated with PCSK9i (evolocumab or alirocumab) or siRNA (inclisiran)
. Unstable clinical status (hemodynamic or electrical instability)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patients achieving Guideline recommended LDL-Cholesterol goal
. Uncontrolled cardiac arrhythmias, defined as recurrent, symptomatic ventricular tachycardia or atrial fibrillation or flutter with rapid ventricular response
. Severe renal dysfunction, defined by eGFR \< 30 mL/min/1.73 m2
. Active liver disease or liver dysfunction, reported in the medical record or defined by AST or ALT levels \> 3 times the upper limit of normal.
. Reported intolerance to statins defined by the following criteria: inability to tolerate at least two different statins; intolerance associated with confirmed and intolerable statin-related adverse effects or significant biomarker abnormalities; improvement/resolution of symptoms or biomarkers following dose decrease or discontinuation; symptoms or changes in biomarkers not attributable to established predispositions.
. Treatment with systemic steroids or systemic cyclosporine within the past 3 months (e.g., intravenously, intramuscularly, or orally)
. Known active infection or severe hematologic, metabolic, or endocrine dysfunction as judged by the Investigator.